Flt(18f) Sinektik

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

FLT (F) Synektik, 1000 MBq/ml, solution for injection

fluorodeoxythymidine (F)

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a specialist doctor in nuclear medicine who supervises the examination.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the specialist doctor in nuclear medicine. See section 4.

Table of contents of the leaflet:

• 1. What is FLT (F) Synektik and what is it used for
• 2. Important information before using FLT (F) Synektik
• 3. How to use FLT (F) Synektik
• 4. Possible side effects
• 5. How to store FLT (F) Synektik
• 6. Package contents and other information

1. What is FLT (F) Synektik and what is it used for

This medicine is intended exclusively for diagnostic purposes.
FLT (F) Synektik is intended to determine the location of malignant tumors, thanks to
the ability to mark cells in which very intense division processes occur.
FLT (F) Synektik contains the radioactive substance fluorodeoxythymidine (F) and is
used in examinations by positron emission tomography (PET). The medicine FLT (F) Synektik is administered before the examination.
After administering a small amount of FLT (F) Synektik, the doctor will take pictures with a special device
(tomograph), on the basis of which they will assess the patient's condition and progress in treating the disease.
The doctor will administer the medicine only if the clinical benefits of using the radiopharmaceutical product
are greater than the risks associated with exposing the patient to ionizing radiation.

2. Important information before using FLT (F) Synektik

When not to use FLT (F) Synektik

• If the patient is allergic to fluorodeoxythymidine (F) or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Particular caution should be exercised when using FLT (F) Synektik:

• if the patient is pregnant or thinks she may be pregnant;
• if the patient is breastfeeding;
• if the patient's kidneys do not work properly; in such a case, it is necessary to carefully consider the indication for the examination, as the patient may be exposed to increased radiation;

Before administering FLT (F) Synektik:

• the patient will receive a recommendation from the doctor to drink a lot and urinate frequently.

After administering FLT (F) Synektik:

• for the first 12 hours after injection, the patient is advised to avoid close contact with small children and pregnant women.

Children and adolescents

This medicine is intended exclusively for adult patients.

FLT (F) Synektik and other medicines

The patient should inform the specialist doctor in nuclear medicine about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as other medicines may affect the assessment of the examination results.

FLT (F) Synektik with food and drink

There are no known restrictions on the type of food and drink consumed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, she should consult a doctor in nuclear medicine before using this medicine.

Pregnant patients

The doctor in nuclear medicine will decide to use FLT (F) Synektik in women with a positive pregnancy test only if the expected benefits for the woman from administering this medicine outweigh the risk to the fetus associated with administering the medicine. If the estimated dose for the fetus is less than 1 mSv, the administration of the radiopharmaceutical is acceptable in justified cases.

Breastfeeding patients

After injecting FLT (F) Synektik, breastfeeding should be interrupted for 12 hours and the expressed milk should be discarded during this time.
The resumption of breastfeeding should be agreed upon with the specialist doctor in nuclear medicine who performs the examination. Before administering the radiopharmaceutical, a sufficient amount of milk can be expressed and stored for later use.
Breastfeeding women are advised to avoid close contact with small children for 12 hours after administering fluorodeoxythymidine (F).

Driving and using machines

FLT (F) Synektik has no influence or negligible influence on the ability to drive and use machines.

FLT (F) Synektik contains sodium

This medicine, in a maximum dose of 10 ml, may contain no more than 33.5 mg of sodium, which corresponds to 1.7% of the WHO-recommended maximum daily sodium intake for adults (2g). This should be taken into account in patients on a low-sodium diet.

FLT (F) Synektik contains ethanol

This medicine, in a maximum dose (10 ml), contains 790 mg of alcohol (ethanol), which corresponds to 20 ml of beer or 8 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use FLT (F) Synektik

The use of radiopharmaceuticals, handling, and disposal are strictly regulated by relevant regulations. FLT (F) Synektik will be used exclusively in specially controlled rooms and administered to patients in accordance with radiological protection rules by trained and qualified medical staff. These staff will strictly follow the rules for safe use of the medicine and inform the patient about the procedures being performed.
The specialist doctor in nuclear medicine supervising the examination will select the appropriate dose of FLT (F) Synektik for each patient. This will be the smallest amount of medicine that allows the examination to be performed.
The recommended activity for an adult patient with a body weight of 70 kg is from 150 to 600 MBq of fluorodeoxythymidine (F) (the dose should be selected individually based on body weight and/or depending on the type of imaging technique used, clinical image, patient condition, and information collected during the interview).

Administration of FLT (F) Synektik and performance of the examination

The medicinal product FLT (F) Synektik is administered by direct intravenous injection.
The examination is performed 15-30 minutes after intravenous administration.
Before administration, the patient will receive a recommendation from the doctor to drink a lot and urinate frequently.
This is intended to reduce the exposure of the urinary system to the harmful effects of radiation.

Duration of the examination

The specialist doctor in nuclear medicine will inform the patient how long the examination will take.

After administering FLT (F) Synektik:

• avoid close contact with small children and pregnant women for 12 hours after injection;
• urinate frequently to accelerate the removal of the medicine from the patient's body.

The specialist doctor in nuclear medicine will provide the patient with appropriate information regarding special recommendations for post-administration procedures if necessary.

Use of a higher than recommended dose of FLT (F) Synektik

This medicine is administered under the strict supervision of a doctor in nuclear medicine, so its overdose is very unlikely. However, if an overdose occurs, the patient will receive appropriate treatment.
In case of any additional questions about the use of the medicine, you should consult the specialist doctor in nuclear medicine who supervises the examination.

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everybody gets them.
FLT (F) Synektik emits a small amount of radioactive radiation, which is associated with a small risk of developing tumors and birth defects.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform the specialist doctor in nuclear medicine.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store FLT (F) Synektik

The patient will not store this medicine. Radiopharmaceuticals are stored in accordance with national regulations on radioactive materials.
The information below is intended exclusively for medical professionals.
Store at a temperature below 25°C. Do not freeze.
Shelf life: 14 hours from the end of synthesis.
After first opening, store at a temperature below 25°C and use within 8 hours, without exceeding the shelf life stated on the label.
Do not use the medicine after the expiration date stated on the label:
Expiration date (EXP): {DD MM YYYY HH:MM}.
Use only a clear solution, without visible particles.

6. Package contents and other information

What FLT (F) Synektik contains

1 vial contains:
Active substance: fluorodeoxythymidine (F) 1000 MBq/ml on the day and time of calibration.
Excipients: water for injections, citrate buffer* with a pH of 5.2, ethanol.
*disodium hydrogen citrate, sodium citrate, hydrochloric acid, water for injections, sodium chloride.

What FLT (F) Synektik looks like and what the package contains

FLT (F) Synektik is a clear, colorless or yellow solution without visible particles.
A 25 ml multidose vial made of type I colorless glass, closed with a bromobutyl rubber stopper and secured with an aluminum ring.
The vial contains from 1 ml to 20 ml of solution, which corresponds to an activity of 1000 to 20,000 MBq/vial on the day and time of calibration.
Expiration date (EXP)
Batch number (Lot)

Marketing authorization holder and manufacturer

Marketing authorization holder

Synektik Pharma Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 3
00-728 Warsaw
Poland
e-mail: synektikpharma@synektik.com.pl

Manufacturer

Synektik Pharma Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland
Date of last update of the leaflet:MM/YYYY
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: https://www.urpl.gov.pl .
-------------------------------------------------- -------------------------------------------------- ------------
Information intended exclusively for medical professionals:
In order to provide medical professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product, the full Summary of Product Characteristics (SmPC) of FLT (F) Synektik is attached to the packaging.